from Humans Are Free:
Moncef Slaoui, the official head of Operation Warp Speed, told the Wall Street Journal last week that all Warp Speed vaccine recipients in the US will be monitored by “incredibly precise … tracking systems” for up to two years and that tech giants Google and Oracle would be involved.
by Whitney Webb
Last week, a rare media interview given by the Trump administration’s “Vaccine Czar” offered a brief glimpse into the inner workings of the extremely secretive Operation Warp Speed (OWS), the Trump administration’s “public-private partnership” for delivering a Covid-19 vaccine to 300 million Americans by next January. What was revealed should deeply unsettle all Americans.
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During an interview with the Wall Street Journal published last Friday, the “captain” of Operation Warp Speed, career Big Pharma executive Moncef Slaoui, confirmed that the millions of Americans who are set to receive the project’s Covid-19 vaccine will be monitored via “incredibly precise … tracking systems” that will “ensure that patients each get two doses of the same vaccine and to monitor them for adverse health effects.”
Slaoui also noted that tech giants Google and Oracle have been contracted as part of this “tracking system” but did not specify their exact roles beyond helping to “collect and track vaccine data.”
The day before the Wall Street Journal interview was published, the New York Times published a separate interview with Slaoui where he referred to this “tracking system” as a “very active pharmacovigilance surveillance system.”
During a previous interviewwith the journal Science in early September, Slaoui had referred to this system only as “a very active pharmacovigilance system” that would “make sure that when the vaccines are introduced that we’ll absolutely continue to assess their safety.” Slaoui has only recently tacked on the words “tracking” and “surveillance” to his description of this system during his relatively rare media interviews.
While Slaoui himself was short on specifics regarding this “pharmacovigilance surveillance system,” the few official documents from Operation Warp Speed that have been publicly released offer some details about what this system may look like and how long it is expected to “track” the vital signs and whereabouts of Americans who receive a Warp Speed vaccine.
Two official OWS documents released in mid-September state that vaccine recipients—expected to include a majority of the US population—would be monitored for twenty-four months after the first dose of a Covid-19 vaccine is administered and that this would be done by a “pharmacovigilance system.”
In the OWS document entitled “From the Factory to the Frontlines,” the Department of Health and Human Services (HHS) and the Department of Defense (DOD) stated that, because Warp Speed vaccine candidates use new unlicensed vaccine production methods that “have limited previous data on safety in humans . . . the long-term safety of these vaccines will be carefully assessed using pharmacovigilance surveillance and Phase 4 (post-licensure) clinical trials.”
The key objective of pharmacovigilance is to determine each vaccine’s performance in real-life scenarios, to study efficacy, and to discover any infrequent and rare side effects not identified in clinical trials. OWS will also use pharmacovigilance analytics, which serves as one of the instruments for the continuous monitoring of pharmacovigilance data. Robust analytical tools will be used to leverage large amounts of data and the benefits of using such data across the value chain, including regulatory obligations.
In addition, Moncef Slaoui and OWS’s vaccine coordinator, Matt Hepburn, formerly a program manager at the Pentagon’s controversial Defense Advanced Research Projects Agency (DARPA), had previously published an article in the New England Journal of Medicine that stated that “because some technologies have limited previous data on safety in humans, the long-term safety of these vaccines will be carefully assessed using pharmacovigilance surveillance strategies.”
The use of pharmacovigilance on those who receive the vaccine is also mentioned in the official Warp Speed “infographic,” which states that monitoring will be done in cooperation with the Food and Drug Administration (FDA) and the Centers for Disease Control and Protection (CDC) and will involve “24 month post-trial monitoring for adverse effects.”
In a separate part of that same document, OWS describes one of its “four key tenets” as “traceability,” which has three goals: to “confirm which of the approved vaccines were administered regardless of location (private/public)”; to send a “reminder to return for second dose”; and to “administer the correct second dose.”
Regarding a Covid-19 vaccine requiring more than one dose, a CDC documentassociated with Operation Warp Speed states:
For most Covid-19 vaccine products, two doses of vaccine, separated by 21 or 28 days, will be needed. Because different Covid-19 vaccine products will not be interchangeable, a vaccine recipient’s second dose must be from the same manufacturer as their first dose. Second-dose reminders for vaccine recipients will be critical to ensure compliance with vaccine dosing intervals and achieve optimal vaccine effectiveness.
The CDC document also references a document published in August by the Johns Hopkins Center for Health Security, associated with the Event 201 and Dark Winter simulations, as informing its Covid-19 vaccination strategy.
The Johns Hopkins paper, which counts Dark Winter co-organizer Thomas Inglesby as one of its authors, argues that existing “passive reporting” systems managed by the CDC and FDA should be retooled to create “an active safety surveillance system directed by the CDC that monitors all [Covid-19] vaccine recipients—perhaps by short message service or other electronic mechanisms.”
Despite the claims in these documents that the “pharmacovigilance surveillance system” would intimately involve the FDA, top FDA officials stated in September that they were barred from attending OWS meetings and told reporters they could not explain the operation’s organization or when or with what frequency its leadership meets. The FDA officials did state, however, that they “are still allowed to interact with companies developing products for OWS,” STAT news reported.